Academic Health Center, University of Minnesota Fairview Health Systems

University of Minnesota Physicians

TIME AND STUDY COLLECTION SYSTEM (TASCS)

CLINICAL RESEARCH BUDGETING/BILLING SYSTEM AND PROCESS USER GUIDE

Version Date: September 3, 2008

2 Revised 9/3/2008

TABLE OF CONTENTS 1. HISTORY OF THE TASCS DATABASE......................................................................4

2. BACKGROUND OF BUDGETING/BILLING COMPLIANCE IN CLINICAL RESEARCH 5

3. WHAT GOES INTO TASCS? ....................................................................................6

4. TIME FRAME OF APPLICABLE CLINICAL RESEARCH.............................................8

5. SUGGESTED ROLES AND RESPONSIBILITIES.......................................................9

Investigator.............................................................................................. 9

Protocol Contact/Research Coordinator ....................................................... 9

Billing Contact/Administrator...................................................................... 9

Service Providers ...................................................................................... 9

Web Application Support Specialist ............................................................10

Academic Health Center (AHC) Information Systems (IS) ............................10

Institutional Review Board (IRB) ...............................................................10

Sponsored Protocols Administration (SPA)..................................................11

Assistant Vice President for Research – Academic Health Center ..................11

6. GENERAL INFORMATION – NAVIGATING IN TASCS...........................................12

Getting User Access to TASCS...................................................................12

Logging In to TASCS ................................................................................13

Saving and Timing Out .............................................................................14

7. THE PROCESS – STEP BY STEP............................................................................16

Researcher Responsibilities .......................................................................16

Protocol Entry Screen ......................................................................................................................18 Frequently asked questions about the Protocol Entry screen:..........................................................19 Visit Entry Screen ............................................................................................................................20 Select Services Entry Screen............................................................................................................23

Service Provider Responsibilities................................................................26

Provider Pricing Entry .....................................................................................................................27 Researcher Responsibilities .......................................................................28

Account and Lab Set-Up Entry Screen ............................................................................................29 Service Provider Responsibilities................................................................31

Researcher Responsibilities .......................................................................32

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Complete Subject Entry Screen .......................................................................................................33 Studies with a Certificate of Confidentiality....................................................................................34 Complete Subject Tracking Form Entry Screen ..............................................................................35 Service Discrepancy Entry Screen ...................................................................................................37

7. COMPLIANCE ......................................................................................................39

8. Reports ...............................................................................................................40

APPENDIX A ..............................................................................................................47

APPENDIX B – User Field Definitions ........................................................................48

APPENDIX C ..............................................................................................................60

APPENDIX D – Process Flow .....................................................................................64

APPENDIX E – AHC Policy .........................................................................................67

APPENDIX F – UMP Policy .........................................................................................71

APPENDIX G – Fairview Policy ..................................................................................72

APPENDIX H – Service Locations ..............................................................................76

APPENDIX I – Fairview / UMP Research Contacts ....................................................78

FAIRVIEW HEALTH SERVICES...................................................................78

UNIVERSITY OF MN PHYSICIANS..............................................................78

ANCILLARY DEPARTMENT CONTACTS .......................................................79

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1. HISTORY OF THE TASCS DATABASE

Established, 1998, by the Research Services Organization to support clinical trial business (not clinical trial data) management

Developed internally by AHC Information Systems developer

Rolled out in July, 1999

Viewing rights for select reports given to department administrators in 2004

Cancer Center Clinical Trials office implements TASCS for time card/billing in fall, 2007

Budgeting/billing compliance TASCS upgrades summer, 2008

Upgraded TASCS in production mode August 18, 2008

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2. BACKGROUND OF BUDGETING/BILLING COMPLIANCE IN CLINICAL RESEARCH

Clinical research is a fundamental and critically important component of any Academic Health Center’s mission. It is also an activity that is highly regulated, deeply complex and thus, carries an inherent risk. Locally, as well as nationally, there has been a lack of communication intra- and inter-organizationally regarding clinical research processes. Clinical trial budgeting and billing is one of those processes that has become an identified risk area. Historically, there have been very few, or no, policies and processes defining or guiding this activity. The University’s Academic Health Center, UMPhysicians and Fairview Health Services have collaborated to create organizational policies in order to address clinical research budgeting and billing. The goal in creating policies is to foster compliant clinical research budgeting and billing across our organizations. Elements of a successful program include the following:

• Integrate language and practice – consent form, clinical trial agreement, billing practice

• Define payers for protocol services prospectively • Identify research participants within the providers’ systems • Identify research related services at point of care – assign to correct payers • Correctly code claims

A process diagram has been crafted to demonstrate the steps involved in implementing the budgeting and billing policy. The process diagram can be found in Appendix D of this manual. The AHC Database (TASCS) is a central tool developed to help support and manage the process.

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3. WHAT GOES INTO TASCS? The AHC policy states that clinical research meeting the following definition must be entered into TASCS. Clinical research is defined as a systematic investigation, including research development, testing and evaluation involving human subjects, their data, records or tissue and is designed to develop or contribute to generalizable knowledge. Clinical research meeting the Institutional Review Board (IRB) criteria for exemption (per 45 CFR 46.101) does not have to be entered into the AHC database. Humanitarian Use Device (HUD)/Humanitarian Device Exemptions (HDE) According to federal definition (21 CFR 814), HUDs/HDEs are not clinical research. However, the same regulation also requires IRB approval to use these devices and Medicare regulations require that the HDE number appear on any submitted claims. Therefore, information related to the use of HUDs/HDEs must also be entered into the AHC Database. Until further notice, the following clarifications to implementation of the policy will be enforced. Please read the following clarifications carefully.

Type of protocol TASCS Screen to complete

For ongoing studies that will use Fairview and/or UMP to provide services required by the protocol (services required to answer the research question)

• Protocol Entry • Visit Entry (for each visit defined by the research protocol –do not have to complete the check boxes next to the visit • Subject Entry (for each ACTIVE subject in the study -inactive/completed/withdrawn subjects do not have to be entered) • Subject Tracking Form Entry (for each research visit for ACTIVE subjects that occurs on or after September 1, 2008)

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For new studies that will use Fairview and/or UMP to provide services required by the protocol (services required to answer the research question)

• Protocol Entry • Visit Entry (for each visit defined by the research protocol – services needed check boxes must be completed for ALL services required to answer the research question) • Select Services Entry (all services must be entered whether they will be provided by Fairview, UMP or some other provider) • Account/Lab Set-Up Entry • Subject Entry • Subject Tracking Form Entry

Question Response 1 Do completed subjects enrolled in ongoing studies need to

be entered into TASCS? No

2 If the study remains open with the IRB (e.g., for data analysis), but all subject visits are completed, does the study need to be entered into TASCS?

No

3 Do all new protocols need to be entered into TASCS if no tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services or hospital services will be required from UMP or Fairview to carry out the protocol?

Not at this time. You are welcome to add these protocols to TASCS; however, you are not required to enter them.

4 If the ongoing study includes active participants, but no services from UMP or Fairview will be required to carry out the protocol, does it need to be entered into TASCS?

No

5 Our research involves consenting subjects and conducting focus groups and surveys. There are no clinic visits, labs, procedures, etc. Do these studies need to go into TASCS?

Not at this time. You are welcome to add these protocols to TASCS; however, you are not required to enter them.

6 Do we have to enter our new studies into TASCS when we never charge the patient (or insurance) for any services? Any services we need are always paid for by the study.

If your protocol requires any tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services or hospital services that will be provided by Fairview or UMP, the protocol must go into TASCS.

7 Does the study have to go into TASCS if we’re only using GCRC services?

Consult with the GCRC to determine if they are purchasing services from Fairview or UMP for your protocol. If not, you do not need to enter your study into TASCS. If the GCRC is using Fairview or UMP services for your protocol, then the study must go into TASCS.

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4. TIME FRAME OF APPLICABLE CLINICAL RESEARCH 1. Applicable clinical research means a clinical research protocol that is planned,

initiated or is ongoing as of September 1, 2008.

1.a Planned means study is undergoing consideration and feasibility assessment

1.b Initiated means a clinical research protocol that has been submitted to

the IRB and has been granted approval OR is pending approval. 1.c Ongoing means the clinical research protocol remains open for

enrollment, or enrollment is closed but existing subject visits that will require services from Fairview or UMP continue.

For these studies, only the following screens need to be completed:

o Protocol Entry o Visit Entry o Subject Entry o Subject Tracking Form Entry

2. Clinical research protocols that are completed on or before September 1,

2008 do not need to be entered into the AHC database.

2.a Completed means closed with the IRB. 3. The same time parameters are applicable to HUDs/HDEs.

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5. SUGGESTED ROLES AND RESPONSIBILITIES Defining roles and responsibilities will lend clarity and improve efficiencies in the overall research process. The following are suggested responsibilities related to using TASCS - categorized by role:

Investigator May enter clinical research information for each clinical research protocol into TASCS. Print a copy of the billing grid report, sign it, and submit it with the initial IRB application and the final SPA Proposal Routing Form (PRF). Update TASCS within 72 hours of the following events:

• each subject/participant who signs an initial consent form, • each subject/participant visit that occurs, and • each subject/participant who ends participation in the clinical research.

Protocol Contact/Research Coordinator If delegated to the Protocol Contact/Clinical Research Coordinator by the investigator: enter clinical research information for each protocol into TASCS. Print a copy of the billing grid report, obtain principal investigator’s signature, and submit signed billing plan with the initial IRB application and the final SPA (PRF). Update TASCS within 72 hours of the following events:

• each subject/participant who signs an initial consent form, • each subject/participant visit that occurs, and • each subject/participant who ends participation in the clinical research.

Billing Contact/Administrator Review the PRF for signed billing grid report. Assist with purchase order preparation based on budget. Monitor and review reports in TASCS as a tool to assist ongoing account management.

Service Providers Service providers, in this context, are employees of University of Minnesota Physicians or Fairview Research Administration. Service providers will assist investigators in determining whether or not the clinical research protocol meets

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criteria for a Qualifying Clinical Trial under Medicare’s policy. They will continue to provide research prices and set up research billing accounts. Providers will establish a process to identify research participants in applicable systems and use TASCS information to help ensure charges are on the correct billing accounts. They will also facilitate research coding on claims.

Web Application Support Specialist Designs, plans, and coordinates end-user TASCS training. Provides assistance to end-users including assistance with data entry when necessary. Manages TASCS access including collecting, reviewing and processing Access Request Forms, providing correct access privileges, monitoring access and removing access to TASCS as staff and responsibilities change. Manages relationships with end-users, web application developer and external service providers (Fairview and UMP). Develops system documentation including preparation and maintenance of a TASCS User Guide. Identifies technical barriers and end-user concerns and initiates resolutions independently as appropriate or in collaboration with the web application developer. Participates in the development of reports for various stakeholders including end-users and service providers. Participates in the development of policies, procedures, and standards for ensuring the integrity of the database. Monitors TASCS reports to measure compliance with the Policy for Budgeting/Billing Compliance in Clinical Research and communicates compliance concerns appropriately.

Academic Health Center (AHC) Information Systems (IS) Writes and maintains code for web application. Resolves technical barriers and end-user concerns, as appropriate. Participates in the development of reports for various stakeholders including end-users and service providers. Participates in the development of policies, procedures, and standards for ensuring the integrity of the database.

Institutional Review Board (IRB) Serves as a checkpoint to help assure congruent language and practice in the research consent process. Reviews language in the consent form regarding cost to the participant and matches information to the signed billing grid report. Notifies principal investigator when discrepancies are identified. Final IRB approval may not be granted until discrepancies are resolved.

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Sponsored Protocols Administration (SPA) Serves as a checkpoint to help assure congruent language and practice in budgeting and billing. Reviews the contract language, proposed budget and signed billing grid report to look for uniformity. Notifies principal investigator and request revisions if discrepancies are identified. Contract or agreement may not be executed until discrepancies are resolved.

Assistant Vice President for Research – Academic Health Center Communication lead, and AHC budgeting/billing for clinical research policy owner. Responsible for policy compliance.

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6. GENERAL INFORMATION – NAVIGATING IN TASCS

Getting User Access to TASCS Cancer Center Clinical Trials Office and Office of Clinical Research staff who had access to the previous production version of TASCS do not have to complete a TASCS Access Application form. However, all of these users must complete training in the upgraded version of TASCS. Before access to TASCS is granted, each prospective user must complete a TASCS Access Application form (see Appendix A on page 47). The application is also available electronically, via the Office of Clinical Research website: www.ahc.umn.edu/ocr/. Researchers and research staff will be asked to identify one or more of the following roles to which they should be assigned: investigator, protocol contact and/or billing contact. Individuals may select all three if they choose. Selecting a role or roles does not mean an individual must serve in that role to view information in TASCS. Service providers, IRB and SPA users should indicate their affiliation on the TASCS Access Application Form. If you have any questions about how to complete the TASCS Access Application Form please call Trung Ngo at 612-626-5203 . The steps are:

A. Complete and print the signature page. Scan and e-mail to TASCS Web Application Specialist at ngox0035@umn.edu

B. If you need a supervisor signature, you should complete the form and forward it to your supervisor for approval. The supervisor may email approval to the TASCS Web Application Specialist at ngox0035@umn.edu

C. You may also choose to complete and print the signature page and then

send it via intercampus mail to:

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Trung Ngo TASCS Web Application Specialist Mail Code 1932 717 Delaware Street SE Minneapolis MN 55455

Applications will be processed as soon as possible, and always within one business day of receipt. Applicants will receive an e-mail notice that access has been granted. Security in TASCS All persons granted access to TASCS will have read and write privileges in the system. TASCS will record the person responsible for the last data changes made to any field in the system. Please be careful when viewing TASCS screens. Except for the following users, TASCS access will be granted based on DeptID. Careful completion of the DeptID section of the TASCS Access Application form will insure access to the information users need. DeptIDs can be added and deleted as needed for each user. Exceptions to DeptID access include:

• Cancer Center Clinical Trials Office (access granted based on protocols entered by CTO staff and/or CPRC number)

• Office of Clinical Research (access granted based on protocols entered by OCR)

• Institutional Review Board (access to all protocol screens and all reports except the researcher’s version of the Subject Tracking Form Report)

• Sponsored Projects Administration (same access as the IRB) • Service Providers (access to all)

Logging In to TASCS The production address for TASCS is http://tascs.ahc.umn.edu. In production environments, the log in screen defaults to the University x500 ID validation screen.

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University employees: University employees will use this screen with their x500 ID and password to log in to TASCS. Non-university employees: Non-University employees should click on the “AHC Login” button at the top of the screen to get to a new log in screen. Non-University employees will need to have a username and password assigned to them via the new user set-up application process.

Saving and Timing Out TASCS will prompt the user to save work before exiting screens. Some screens allow two options – “Save” and “Save/Submit”. Users should choose “Save” while still working on the entry screen. Once a screen is complete, choose “Save/Submit”. Selecting this option will send e-mail notification to service providers that your request is ready for processing. While TASCS allows some amount of time before timing out, users are encouraged to save work frequently and whenever data entry in TASCS is interrupted. When attempting to close a TASCS entry screen before saving, the following message will appear:

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The following navigation tools may be useful to use when entering information in TASCS:

Keys Description Alt + Left Arrow Back a page. Alt + Right Arrow Forward a page. ALT + D Select the address bar so you can enter a new URL HOME Brings you to the top of the page END Brings you to the bottom of the page TAB Skip to the next field SHIFT + TAB Skip to the last field CTRL + A Select all CTRL + C Copy CTRL + V Paste

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7. THE PROCESS – STEP BY STEP The following information describes the data entry and communication process from beginning to end. Sections of the process are divided between Researcher Responsibilities (most commonly meaning either investigator or protocol contact responsibilities) and Service Provider (meaning UMP or Fairview) responsibilities. A complete list of all TASCS entry screen fields can be found in Appendix B starting on page 48. It is important to guard against the duplicate entry of protocols in TASCS. Researchers can check a list of protocols already entered in TASCS by going to the Edit menu and choosing Protocol. Searching by PI will yield the list of protocol short titles, sponsors, etc. that will help users determine whether or not the protocol might already be entered. Whenever there is a question – the user should check before entering a new protocol. It is recommended that the primary protocol contact for a protocol be responsible for setting up new protocols in TASCS – but researchers and departments can determine how to best assign responsibilities. The Web Application Support Specialist will, on a regular basis, search for duplicate entries and work with protocol contacts to correct any multiple entries of protocols in TASCS.

Researcher Responsibilities Adding a new Sponsor, Principal Investigator, Billing Contact or Protocol Contact Every effort will be made to prevent duplicate entries of sponsors, and persons (including investigators, billing contacts, protocol contacts, etc.) in TASCS. When entering a new protocol in TASCS, if the Sponsor or Person is not listed as a current drop down option, the Web Application Support Specialist will enter the new Sponsor or Person into TASCS. When a sponsor, investigator, billing contact or protocol contact must be added – the user should e-mail or fax the required new information to the Web Application Support Specialist at:

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U of M, Academic Health Center TASCS Web Application Specialist

Mail Code 1932 717 Delaware St SE,

Minneapolis MN 55455 Fax: 612-624-49831 need to correct

Phone: 612-626-5203 E-mail: ngox0035@umn.edu

Information needed to enter a new Sponsor or new Person in TASCS can be found in Appendix C (page 60). It is important to note that every Sponsor entered in TASCS has a funding source associated with that Sponsor. The selection of the appropriate funding source has implications for assuring the proper rates for research services are applied. If you have questions about the funding source associated with a Sponsor please contact Trung Ngo. For more information about funding sources please see the Sponsor request form in Appendix C (page 63). The IRB and SPA will review a budgeting/billing grid as part of all new protocol applications received after September 1, 2008. To prepare a budgeting/billing grid, follow the steps described in the next sections.

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Protocol Entry Screen

Before entering a new protocol, go to Appendix B, and find the Protocol Entry Screen list of fields. Until you are familiar with TASCS – use the list of fields to review the definition of what should be entered in each field. Fields that must be entered to “Save” the protocol are marked with a red asterisk on the entry screen. Fields that are required, but not required to “Save” are indicated with a blue asterisk and must be completed if they apply to the protocol. Fields that are not required can be used at the discretion of the user. Go to the “New” menu and choose “Protocol”. The Protocol Entry Screen includes basic information about the study. Remember to Save! TASCS will prompt for required fields’ data entry before a new protocol can be saved. The field definitions for the Protocol Entry Screen can be found on pages 48-59 of Appendix B (which starts on page 48 of this manual).

Screen 1: Protocol Entry

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Frequently asked questions about the Protocol Entry screen: How should multiple sponsors be attached to a single protocol?

Information on this subject will be added to the TASCS manual. TASCS lets you indicate one sponsor in the system. If the protocol is investigator-initiated, choose “Investigator-initiated” .with the appropriate funding source in parenthesis. If any of the sponsors is a governmental department or agency, list that sponsor in the sponsor field. If the study sponsor is a non-profit entity (University, foundation, etc.) and there is no governmental sponsor, list the non-profit entity in the sponsor field. If all the sponsors are commercial (a business or industry), pick one to list in the sponsor field. In all instances, you may provide the names of other sponsors in the comment section, but they are not required.

Which sponsor should be chosen in TASCS when the study is investigator-initiated, but funding is provided by a commercial source (business or industry)?

Choose “Investigator-initiated (B&I)” from the sponsor drop down list. You can identify the commercial sponso’s name in the comment field if you like, but it is not required.

How do you enter a single IRB protocol into TASCS when the protocol has multiple funding sources and titles? Currently, the study has separate account numbers based on title and funding source?

For projects such as these we’ll have to use the EFS account string as the unique identifier rather than the IRB number. Each EFS account string will require its own Protocol Entry into TASCS. Work with your department accountant.

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Visit Entry Screen

After the Protocol Entry Screen is completed, go to the “Edit” menu and choose “Visit Entry”. Search by TASCS number (or any search term of your choosing) for the Visit Entry screen and choose “Search”.

Screen 2: Visit Entry lookup

Before entering any data, go to page 53 in Appendix B and find the Visit Entry Screen list of fields. Until you are familiar with TASCS – use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact.

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Screen 3: Visit Entry sample

All data collection time points must be defined and entered as uniquely named visits in TASCS. Visits should be defined based on the protocol time points at which research data will be collected for each subject. Four visit descriptions (startup, consent, date withdrawn, and a reason for the subject withdrawal) are autofilled by TASCS. (The startup visit description is available for business use outside of the budgeting/billing policy but may be used to store optional information about startup activity.) All other visits can be named at the user’s discretion. Common labels include numbering visits such as Visit 1, Visit 2, etc. Other possibilities include Day 1, Day 7, Day 14, etc. Visits should include a number, and be identified in the way that will make information most useful to the researcher.

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Check the box for each visit at which any medical or laboratory services will be needed whether they will be provided by Fairview, UMP or any other provider.Medical or lab services refers to tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services or hospital services that are required to carry out the protocol. When all available lines have been entered – simply hit “Save Changes” and four more blank lines will be made available. If you discover, after naming visits, that you must add a visit that would occur between visits already named, name a new visit on a blank line and use the Order column to indicate in what order the visit should occur. When you select “Save” TASCS will re-order the visits. Remember to Save whenever your work is interrupted. Do not select “Save Changes/Select Services” until all of your visit descriptions have been entered. If you accidentally choose “Save Changes/Select Services” button and you are not finished entering visits just choose “Edit” Visits to continue. Please note that you can delete visits from the Visit Entry screen. There is a check box at the end of each Visit row to “Delete”. Use this button with caution as deleting a visit will delete all stored data related to that visit (services, visits completed, etc.) It is not recommended that users delete visits from the Visit Entry screen after any study visits for subject have actually occurred. When all visits have been named, choose “Save Changes/Select Services”. The Select Services screen will appear.

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Select Services Entry Screen

Screen 4: Select Service lookup

Before entering any data, go to page 53 in Appendix B and find the Select Services Entry Screen list of fields. Until you are familiar with TASCS – use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact.

Screen 5: Select Services sample

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Most of the Fairview e-form research request process will be replaced by TASCS. It will no longer be necessary to complete a Fairview e-form for pricing or account set-up activities. Four lines related to Investigational Drug Services (IDS) will be autofilled by TASCS on the Select Services Screen. The service location for IDS services will also be autofilled. All medical or laboratory services (tests, procedures, clinic space, clinic visits, physician time, lab services, pharmacy services, or hospital services that are required to carry out the protocol must be entered on the Select Services Entry Screen whether they will be provided by Fairview/University of Minnesota Physicians or not. Researchers will be asked to enter medical and laboratory services – one line for each service location. What this means is that if the protocol will require imaging (MRIs, for instance) at both a Fairview facility and at the UMP Imaging Center – MRIs must be listed twice on the Select Services Screen. Enter the name of each test or procedure using the clearest and most specific terms possible to indicate the service needed. For instance, if the MRIs required by the protocol will require the use of a contrast agent, enter “MRI with contrast”. Service providers will communicate with the protocol contact entered in TASCS whenever more information is needed to make sure TASCS reflects what the protocol requires. After naming the test/procedure, the next field to enter will be to select the service location from the drop down. The Service Location drop down includes:

UMMC Clinic UMP Clinic Fairview Clinic (Includes Maple Grove) Fairview Hospital UMP Imaging Center Other

Additional information on categorizing or understanding service locations is available in Appendix H.

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If some of the tests/procedures will be performed at multiple locations, enter the service on as many lines as needed to allow for indicating each Service Location at which protocol services may be provided. Note about choosing a location for laboratory services: If the Outpatient Laboratory (first floor PWB) or a hospital laboratory will be used – choose Fairview Hospital as the location. If clinic laboratory services will be used – choose the appropriate clinic location. If, for example, the protocol will require EKGs to be performed by the Outpatient Laboratory, enter “EKG (Lab) and choose Fairview Hospital as the location. Note about one-time or “invoiceable” services: If the protocol includes services that may be incidental or required only under specific circumstances enter these services (using as clear a description as possible) in the Comment section at the bottom of the Select Services Entry screen. This will allow providers to provide a price for the services. The next field to complete is to indicate how the test/procedure will be paid for at each visit. The drop down options for this field are:

Research Account Patient/Insurance Other

In some studies, a service might be appropriately billed to patient insurance at some visits but not others. TASCS will allow users to indicate how the service should be billed at each visit – or whether it will be provided outside of Fairview or UMP. When all available lines have been entered – select “Save Changes” and more blank lines will be made available. Remember to “Save Changes” whenever your work is interrupted. Do not select “Save Changes/Submit to Fairview and UMP” until all services required by the protocol have been entered. If you prematurely select “Save Changes/Submit to Fairview and UMP” you should contact Fairview to let them know that your request is not yet complete. When all services required by the protocol have been entered on the Select Services Entry Screen, select “Save Changes/Submit to Fairview and UMP”. Service Providers will receive an automatic e-mail (with a copy to the protocol and billing contacts) informing them that there is a protocol for them to review. Researchers will receive a prompt to attach their protocol to an e-mail to send to Fairview and UMP.

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Service Provider Responsibilities Review the submitted protocol and billing plan that is now available as a TASCS report (Billing Grid). If the billing plan indicates that the patient/insurance will be billed for study related services, then further review is required to determine if the study is a qualifying clinical trial under the National Coverage Decision (Medicare’s Clinical Trial Policy). Alert investigators, early in review, if concerns are identified with the billing plan or if the study is not a qualifying clinical trial. When the coverage analysis is completed, providers will click the “Coverage Analysis Complete” button on the Protocol Entry Screen. This will initiate a TASCS generated e-mail to the Protocol Contact and the Billing Contact to inform them that the billing grid is now ready. Researcher Responsibilities After receiving email notification that the billing grid is available, go to the Report menu and select Billing Grid Report. Print the billing grid and have the PI review, sign, and date. Submit the signed/dated billing grid with the IRB application.

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Provider Pricing Entry

Screen 6: Provider Pricing lookup

Select the appropriate fee schedule from the drop down for each service listed based on the service location. Click on the Write-In service description to advance to the pricing screen.

Screen 7: Provider Pricing sample

The Write-In service description and desired service location are provided as header information on the pricing screen. Use the drop-down menu in the Service Description column to locate the requested service. The remainder of the row will auto-populate. If additional services are typically needed (e.g., Colorflow Doppler when “Echo” is requested, or contrast material for Nuclear Medicine tests), add

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the service on the next line. Click the “Save” button to return to the previous screen.

Screen 8: Provider Pricing Entry sample

Continue to price each service requested. When finished choose the “Completed” button. This action generates an email notice to the Protocol and Billing contacts that prices are available.

Researcher Responsibilities To prepare the protocol budget, go to the Report menu and select Research Prices Report. This report will provide the prices for services to be provided by Fairview/UMP and billed to the research account. This information will be based on the data entered on the Select Services Entry Screen. Submit documents to SPA – including consent form and signed/dated billing grid. NOTE: If the consent form submitted to SPA is draft language, the PI is responsible for notifying SPA regarding any changes in the final IRB approved version. When the account number is assigned by SPA – request/prepare a purchase order for the research services that will be paid for by the research account. When a purchase order number is available – it is time to complete the Account/Lab Set-Up Screen.

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Account and Lab Set-Up Entry Screen

Screen 9: Account/Lab Set-up lookup

Before entering any data, go to page 55 in Appendix B to find the Account/Lab Set-Up Entry Screen list of fields. Until you are familiar with TASCS – use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact.

Screen 10: Account/Lab Set-up sample

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Screen 11: Account/Lab Set-up sample

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The lab portion of the Account/Lab Set-Up Entry Screen is almost exactly the same as the current paper form used by the lab. Any questions about how to complete the fields on this screen should be directed to Fairview at (612) 672-7690. If you start to enter data in the General Account Information section of the Account/Lab Set-Up Entry Screen you have to complete the section in order to “Save Changes”. Service providers will receive an email alerting them to establish your accounts when you “Save Changes” for this section. The remaining sections of this entry screen do not need to be populated in order to “Save Changes”. Complete the Lab Instruction Form section and the Recruitment Posting section as applicable to your protocol. After selecting “Save Changes”, a new General Account Information section will appear on the Account/Lab Set-Up Screen. This will allow for additional purchase orders to be added.

Service Provider Responsibilities An email will be automatically generated to Service Providers (with a copy to the Protocol Contact and Billing Contact) for review and set up of account numbers. Fairview Research Administration, UMPhysicians Central Business Office and Fairview Laboratories will review the Account and Lab Set-Up screen. UMPhysicians will assign a Flowcast case number to the study and enter it into TASCS. Fairview will assign hospital account numbers (B#s, S#s, etc.) and laboratory account numbers (U#s) and enter them into TASCS. Providers will communicate with the appropriate contact (either Protocol or Billing) if more information is needed. Providers populate the “Provider Accounts” section on the bottom of the Account and Lab Set-Up screen and choose the “Account Set-Up Complete” button. The Protocol and Billing contacts will receive an email stating the account numbers have been assigned. The account numbers will now appear on the Protocol Entry Screen and on the Account and Lab Set-Up Screen. Visit specific encounter forms are now available within TASCS and may be printed as needed.

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Fairview Lab will continue to create the laboratory requisitions and send to the requesters.

Researcher Responsibilities When enrollment for the protocol can begin and a potential subject is identified – follow these steps:

• Go to the Reports menu. • Print visit specific encounter form(s) from TASCS. The visit specific forms

will include only those services to be provided by Fairview or UMP and to be billed to the research account.

Note about encounter form use: Encounter forms and lab slips signal providers to bill services to the research account. If a service is not listed on an encounter form or lab slip – it will be billed, by default, to the subject or to the subject’s third party provider. One-time or “invoiceable” items should be written in the box on the encounter form and indicated, on the Subject Tracking Form Entry screen, as an additional service not pre-printed on the encounter form. Encounter forms can be printed specific to subjects and visits. It is also possible to print a visit specific encounter form that does not include information about any specific subject. If researchers use these generic forms, information about the subject must be handwritten on the encounter form. Note about encounter forms: Visit and subject specific encounter forms will only be available in TASCS if the Select Services Entry screen has been completed. For ongoing clinical research protocols, entering information in the Select Services Entry screen is not required. For these protocols, researchers will continue to use the encounter forms Faiview issued for the protocol.

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Complete Subject Entry Screen

Screen 12: Subject lookup

Before entering any data, go to Appendix B to find the Subject Entry Screen list of fields. Until you are familiar with TASCS – use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact.

Screen 13: Subject Entry sample

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Within 72 hours of a subject signing a consent form – enter information about the subject into the Subject Entry Screen and the date of consent in the Subject Tracking Form Entry screen. By entering the date of consent in the Subject Tracking Form Entry screen, providers will receive an automatic e-mail notification that a subject has been enrolled and that a patient case number needs to be assigned, if necessary. The Protocol Contact and Billing Contact will receive an e-mail when the case number has been assigned.

Studies with a Certificate of Confidentiality These studies typically have no services billed to insurance. Real initials, date of birth and medical record numbers need not be entered. By indicating, on the Protocol Entry Screen, that the study has or will have a Certificate of Confidentiality, TASCS will autofill placeholder information in the initials, medical record number and date of birth fields on the Subject Entry Screen. This will allow for a billing grid to be created and submitted to the IRB and SPA per the process. There would be no identifying information about subjects within TASCS and the providers would not attempt to flag any patient accounts. Note about case number assignment: UMP will enter case numbers for all subjects entered into the TASCS system on or after August 18, 2008. For subjects that were entered into TASCS prior to August 18, 2008 (Office of Clinical Research and Cancer Center Clinical Trials Office – UMP will either enter the cases, or provide them to the OCR for entry into TASCS).

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Complete Subject Tracking Form Entry Screen

Screen 14: Subject Tracking lookup

Before entering any data, go to page 58 in Appendix B and find the Subject Tracking Form Entry Screen list of fields. Until you are familiar with TASCS – use the list of fields to help you determine which fields are required, and to review the definition of what should be entered in each field. Any fields that are not required can be used at the discretion of the researcher, billing contact or protocol contact.

Screen 15: Subject Tracking Form sample

To repeat instructions about this important step, within 72 hours of a subject signing a consent form – enter information about the subject into the Subject Entry Screen and the date of consent in the Subject Tracking Form Entry screen. By entering the date of consent in the Subject Tracking Form Entry screen, providers will receive an automatic e-mail notification that a subject has been enrolled and that a patient case number needs to be assigned, if necessary. The Protocol Contact and Billing Contact will receive an e-mail when the case number has been assigned.

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Also within 72 hours of any of the following actions – a visit date in the Subject Tracking Form Entry Screen must be entered.

Any subject completing a protocol visit, or Any subject withdrawing from the protocol

Before any visit date can be entered – users are required to answer “yes” or “no” to the following question: Were additional services used at the visit (e.g., not planned for this visit and they were not pre-printed on the Encounter Form or Research Lab Slip)? If there were additional services, indicate by choosing "Yes." If there were no additional services, indicate by choosing "No." Whenever the answer to the question is “yes”, Service Providers will receive an email notification and the Researcher will be prompted to complete another TASCS screen called: Service Discrepancy Entry Screen. This screen looks similar to the original Select Services Screen. Note about added services: One-time or “invoiceable” items should be written in the box on the encounter form and indicated, by answering the question “Y” on the Subject Tracking Form Entry screen for the visit, as an additional service not pre-printed on the encounter form. Note about entering consent date: In studies where consent to participate in the study occurs months in advance of any further screening for eligibility, the date of consent must still be entered within 72 hours after consent is signed. Subjects found to be ineligible will have to be withdrawn from the study when it is known they are ineligible. Note about turnaround time for getting patient/subject case numbers assigned: Case numbers will be assigned within two business days, in many cases, one business day.

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Service Discrepancy Entry Screen

Screen 16: Service Discrepancy lookup

Enter the name of each test or procedure using the clearest and most specific terms possible to indicate the service that was added at the visit.

Screen 17: Service Discrepancy sample

Indicate where the service was provided. The Service Location drop down includes:

UMMC Clinic UMP Clinic Fairview Clinic (Includes Maple Grove) Fairview Hospital UMP Imaging Center Other

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The next field to complete is to indicate who will pay for the added test/procedure at this visit. The drop down options for this field are:

Research Account Patient/Insurance Other

Remember to Save Changes! Service Provider Responsibilities Flag or track patients who are research participants:

• UMP creates patient case numbers and enters into TASCS • Fairview activates a patient flag in the billing system (PASS)

Review TASCS reports daily to close cases and remove patient flags. Daily review of charges on all flagged accounts to determine if charges are on the correct accounts. Add research codes to patient claims as needed. Review TASCS for reports of study closure and close accounts. AHC Responsibilities Under the budgeting/billing compliance policy, study closure will be indicated by completing the field “All Subjects Withdrawn Date”. This date should reflect the date the last subject enrolled (or to be enrolled) in the study has ended his/her participation. Entering this date is a critical step that should be taken as soon as the last subject to be enrolled in the study has completed his/her participation.

• Go to the Edit menu and choose Protocol. • Find the protocol by using the TASCS number (or any other search option). • In the Subject Tracking Form section of the Protocol Entry Screen, enter the

date the last subject in the study has been withdrawn.

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7. COMPLIANCE

The institutional policies (see Appendices E-G) describe the rationale and procedures for compliant budgeting and billing practices within the AHC, University of Minnesota Physicians and Fairview Health Services. As discussed earlier, this is a heavily regulated activity and is viewed as a high-risk area. Compliance will be monitored and reported to Senior Leadership at the AHC, UMPhysicians and Fairview Health Services. The driving principle used to facilitate compliance is to assist all stakeholders in adhering to the defined processes. Resources are available to help with questions, TASCS has automated several process functions, guidance tools have been developed and training is available. Compliance will be managed as follows:

• Users who do not enter their study information into TASCS will be reminded to do so.

• If the requisite data is not entered, within 3 working days after the informal reminder, the TASCS Web Application Support Specialist will make a formal request that the information is entered and copy the AHC Associate VP for Research.

• If the requisite data is not entered within 5 working days of the formal request, the Associate VP for Research will discuss the concern with the principal investigator.

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8. Reports All reports available in TASCS may be used by Researchers and Service Providers. The following reports are available now. The reports that researchers will most commonly use are listed in bold and italics. TASCS users are encouraged to explore the other reports – and consider whether/how storing information in optional fields might be useful. Active Research Subjects Active Study Amendments Budgeted Effort Billing Grid Encounter Form IDE/HDE Study Inactive Study IRB Approval Medical Services Used Protocol Information Purchase Order Expiration Research Pricing Research Subject Study Enrollment Research Visit by Date Subject Tracking Form Subject Tracking Form (IRB) Visit Services

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APPENDICES

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APPENDIX A

48

APPENDIX B – User Field Definitions Protocol Entry

Field Name * Required Response Entered By Field Definition 1 TASCS # n/a Autofill System Sequentially assigned - 2 digits year; 3 digits protocol

2 PI Y Drop down Web app specialist

Principal investigator for the protocol

3 Billing Contact Y Drop down Web app specialist

Protocol business manager - the approver of protocol expenses commonly called administrator or accountant

4 Sponsor Name and Type Y Drop down Web app specialist

Choose the sponsor (the person or group that wrote the protocol). Each sponsor has a funding type associated: Business/Industry, Federal, State, University, Other (see Appendix C for definitions)

5 Sponsor Protocol # Char, any text AHC User Sponsor assigned protocol unique identifier 6 ClinicalTrials.gov # Char, any text AHC User Clinical Trials.gov protocol unique identifier

7 Short Protocol Title Y Char, any text AHC User Abbreviated protocol name - limited to 70 characters (may use acronyms)

8 Full Protocol Title Y Char, any text AHC User Full protocol title (to match IRB and SPA records)

9 CRO (Contract Research Org) Drop down AHC User

Contract Research Organization - commonly employed by business and industry sponsors

10 Protocol Monitor Drop down AHC User Data monitor assigned to the protocol - person who reviews protocol compliance and data collection

11 Status Y Drop down AHC User

Select from drop down options: Active-Approved (ready to enroll); Active-In the Approval Process (work is in process - not ready to enroll); Active-Future Protocol (not working on the protocol yet); Inactive (completed); Inactive (rejected/declined)

12 Inactive Year Y, when inactivated Char, any text AHC User

Year all work on the protocol was completed (or was rejected or declined) - inactivates the protocol in system

13 Protocol Contact Y Drop down Web app specialist

Protocol contact responsible for direct-to-subject contact - commonly called the research coordinator

14 Sponsor Contact Drop down AHC User User select from drop down

15 Department Drop down AHC User Choose the DeptID that will cover this account. Typically, this is the investigator's home department.

16 SPA Contact Autofill System SPA grant administrator working on the protocol

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17 CRO Contact Drop down AHC User Contact person from contract research organization

18 Check here if you need a new subcontract with Fairview or UMP

Check box AHC User

Check the box if you need to purchase labor from Fairview or UMP. Please note that professional fees do not require a subcontract. Contact Fairview or UMP with questions.

19 EFS Fund Y Char, any text AHC User Check with your department for correct financial system identification numbers. TASCS will enter a placeholder until known.

20 DeptID Y Char, any text AHC User Check with your department for correct financial system identification numbers.

20 Program Y Char, any text AHC User Check with your department for correct financial system identification numbers.

21 Project Y Char, any text AHC User Check with your department for correct financial system identification numbers. TASCS will enter a placeholder until known.

22 Fin Emplid Char, any text AHC User Enter the principal investigator's employee ID number.

23 Chartfield1 Char, any text AHC User Check with your department for correct financial system identification numbers. Enter placeholder until known.

24 Chartfield2 Char, any text AHC User Check with your department for correct financial system identification numbers. Enter placeholder until known.

25 Contract # Char, any text AHC User Financial system number assigned to the contract for the protocol. Check with your department for how to find this number.

26 Fund Char, any text AHC User Fund associated with research account - enter 0000 until known

27 Area Autofill System Department numeric identification code

28 Org Char, any text AHC User University numeric identification code for the protocol - enter 0000 until known

29 Start Date Y Month/Day/Year AHC User Protocol Start Date - enter date of protocol entry until firm date is known (firm date should match SPA records)

30 End Date Y Month/Day/Year AHC User Projected protocol End Date - enter date one year from protocol entry date until firm date is known (firm date should match SPA records)

31 First Contact Date Month/Day/Year AHC User Date site was first approached about the study 32 Final Protocol Receipt Date Month/Day/Year AHC User Date final protocol was received for the protocol

33 Contract Exception Drop down AHC User Used to indicate whether a contract remains open until all work is completed or has a firm end date

34 Payment for Screen Fails Yes/No AHC User Used to indicate whether or not the contract with the funder includes payment for subjects who are screened but cannot enroll

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35 Funder Approval Date Month/Day/Year AHC User Date the funder approves the budget for the protocol

36 To Dean Date Month/Day/Year AHC User Date the final Proposal Routing Form and documents go to the Dean for signature

37 Contract Signature Date Month/Day/Year AHC User Date that indicates contract has been executed by all parties (use the latest signature date)

38 Startup Payment Number AHC User Non-refundable start-up payment listed in the contract

39 Total Value Number AHC User Total value of the contract if all subjects completed - (use number from Notice of Grant Award)

40 Estimated $/Subject Autofill System Calculation: Total Value minus Start-Up divided by number of subjects

41 Invoice for Amendments Yes/No AHC User Used to indicate whether or not the contract with the sponsor will provide payment for processing protocol amendments

42 Coverage Analysis Complete Check box Service Provider

Used to indicate to the researcher that Billing Grid Report is ready to be printed, signed by PI and submitted to IRB/SPA.

43 Amendment Number Number AHC User Used to record the number of protocol amendments 44 Amendment Date Month/Day/Year AHC User Record the date of the protocol amendment 45 Amendment Rec'd Date Month/Day/Year AHC User Record the date the protocol amendment was received

46 Amendment Amount Number AHC User The amount (per the contract) that can be invoiced for processing the amendment

47 CPRC Number Y, if applicable Number AHC User Number assigned to the protocol by the Cancer Protocol Review Committee (CPRC)

48 CPRC Application to PI Date Month/Day/Year AHC User

Date the completed CPRC application was given to the investigator for review

49 CPRC Submission Date Month/Day/Year AHC User Date the CPRC application was submitted to the committee

50 CPRC Stipulation Date Month/Day/Year AHC User Date on the CPRC stipulation letter

51 CPRC Stipulation Response Month/Day/Year AHC User

Date the CPRC stipulation response is sent to the investigator for review

52 CPRC Approval Date Month/Day/Year AHC User Date on the CPRC final approval letter

53 OCR/GCRC Scientific Review Number AHC User

Number assigned to the protocol by the Office of Clinical Research/General Clinical Reseach Center

54 OCR/GCRC Application to PI Date Month/Day/Year AHC User

Date the completed OCR/GCRC application was given to the investigator for review

55 OCR/GCRC Submission Date Month/Day/Year AHC User

Date the OCR/GCRC application was submitted to the committee

56 OCR/GCRC Stipulation Date Month/Day/Year AHC User Date on the OCR/GCRC stipulation letter

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57 OCR/GCRC Stipulation Response Month/Day/Year AHC User

Date the OCR/GCRC stipulation letter is sent to the investigator for review

58 OCR/GCRC Approval Date Month/Day/Year AHC User Date on the OCR/GCRC final approval letter 59 Other Scientific Review Drop down AHC User Select the scientific review option that applies

60 Other Scientific Review Number Number AHC User

Number assigned to the protocol

61 Other Application to PI Date Month/Day/Year AHC User Date the application was given to the investigator for

review 62 Other Submission Date Month/Day/Year AHC User Date the application was delivered to the committee 63 Other Stipulation Date Month/Day/Year AHC User Date on the stipulation letter

64 Other Stipulation Response Date Month/Day/Year AHC User

Date the response to stipulations letter is sent to the investigator for review

65 Other Approval Date Month/Day/Year AHC User Date on the final approval letter

66 IRB Application to PI Date Month/Day/Year AHC User Date the application was given to the investigator for review

67 IRB Submission Date Month/Day/Year AHC User Date the IRB application was delivered to the IRB

68 IRB Number

Y- but not required for TASCS to "Save" at

protocol entry.

Char, any text AHC User

Unique identifier - code number used by IRB and SPA to identify protocol

69 IRB Meeting Date Month/Day/Year AHC User Date the IRB will consider the application 70 Certificate of Confidentiality Check box AHC User If a Certificate of Confidentiality is in place - check the box 71 IRB Stipulation Date Month/Day/Year AHC User Date on the initial stipulations letter from the IRB

72 IRB Stipulation Response Date Month/Day/Year AHC User

Date the IRB stipulation response letter is delivered to the investigator for review

73 IRB Approval Letter Rec'd Date Month/Day/Year AHC User

Date final IRB approval letter is received

74 IRB Approval Letter Date Month/Day/Year AHC User Date on the final IRB approval letter

75 IRB Continuing Review Date Month/Day/Year AHC User IRB end of approval date

76 Investigational New Drug # Y, if applicable Char, any text AHC User The investigational new drug (IND) number assigned by the Food and Drug Administration (FDA) If the test article is a biologic - enter the BLA number in this field

77 Investigational Device Exemption Y, if applicable Char, any text AHC User

The investigational device exemption (IDE) number assigned by the FDA

78 Humanitarian Device Exemption Y, if applicable Char, any text AHC User

The humanitarian device exemption (HDE) number assigned by the FDA

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79 Final Monitoring Visit Month/Day/Year AHC User Date the sponsor performs the final monitoring visit and close-out activities

80 Subjects Consented Autofill System The number of subjects who have signed a consent form for the study - pulled from subject tracking entry

81 Subjects Enrolled Autofill System The number of subjects who have signed a consent form for the study and have completed at least one more study visit - pulled from subject tracking form entry

82 Subjects Contracted Number AHC User Total number of subjects estimated to be enrolled in the protocol (from contract, if applicable)

83 Subjects Withdrawn Autofill System Total number of subjects withdrawn - pulled from subject tracking form entry

84 All Subjects Withdrawn Date

Y - but not required for TASCS to "Save" at

protocol entry.

Month/Day/Year AHC User

This date should reflect the date the last subject enrolled (or to be enrolled) in the study has ended his/her participation.

85 First Subject Consent Date Autofill System Date the first subject signed a consent form for the study - pulled from subject tracking form entry

86 End of Enrollment Char, any text AHC User Date that enrollment in the protocol is closed

87 First Subject Enrolled Date Autofill System Date the first subject completes one visit after consent - pulled from subject tracking form entry

88 Lab # Autofill System Lab account number - pulled from lab/account set-up entry screen

89 Hospital Account # Autofill System Hospital account number - pulled from lab/account set-up entry screen

90 Hospital Account # Autofill System Additional hospital account number (if applicable) - pulled from lab/account set-up entry screen

91 EPIC # Autofill System Clinic account number - pulled from lab/account set-up entry screen

92 IDS# Autofill System Investigational drug services account number - pulled from lab/account set-up entry screen

93 Flowcast Study # Autofill System Flowcast study number - pulled from lab/account set-up entry screen

94 Comments Char, any text Any General comments and notes field to store any information useful to the management of the protocol or to communication about the management of the protocol

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Visit Entry

Field Required Response Entered By Field Definition

1 Order Autofill System Order is assigned by TASCS, but visits can be added and the order changed as needed.

2 Description Y Char, any text AHC User

Label for each research subject encounter required by the protocol - i.e., Visit 1, Visit 2; Day 23 Phone Call. Visit names must be unique and must be listed in the order they will occur.

3 Check box if any medical/lab services needed

Y Check box on/off AHC User

Check box if any medical/lab services will be needed from any provider at the visit. See note on Visit Entry screen for definition of medical/lab services.

4 Contract amount Number AHC User The amount, according to the contract, the site will be paid for each subject completing this milestone

5 PI Hours Number AHC User The number of hours budgeted for the investigator to complete his/her work per subject at this milestone

6 Administrator Hours Number AHC User The number of hours budgeted for an employee to complete his/her work per subject at this milestone

7 Coordinator Hours Number AHC User The number of hour budgeted for an employee to complete his/her work per subject at this milestone

Select Services Entry

Field Required Response Entered By Field Definition

1 Requested Test/Procedure Y Char, any text AHC User Enter the requested test/service - free text up to 35 characters

2 Service Location Y Drop down AHC User

Choose the location at which service will be provided (UMMC Clinic, UMP Clinic, Fairview Clinic, Fairview Hospital, UMP Imaging Center, or Other). Services to be provided at multiple locations will have to be added to the Select Services Entry Screen once for each service location.

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3 Payment for Service Y Drop down AHC User Choose the payment for the service at each visit

4 Notes Char, any text AHC User

Enter single use or invoiceable items here. Use this note field to communicate anything about the service request that will help providers understand what is needed.

Service Provider Services Entry

Field Required Response Entered By Field Definition 1 Write-in Service Description Autofill System Free text to ID requested service 2 Service Location Autofill System Directs to appropriate fee schedule

3 Fee Schedule Y Drop down Service Provider Usual & Customary pricing (except IDS, Lab and UMP)

4 Discrepancy Char, any text Service Provider Alerts to new or modified service

5 Notes Autofill System Notes entered by the AHC User on the Select Service Screen

Service Provider Pricing Entry

Field Required Response Entered By Field Definition

1 System Service Description Y Drop down Service Provider

Verify active unique service ID, add associated services as needed

2 Unique ID Autofill System ID specific to fee schedule that locates unique service

3 Gross Price Autofill System Fee schedule price

4 Research Rate Autofill System NIH and other non-profit, or B&I (except lab, IDS and UMP)

5 Calculated Price Autofill System System generated Gross x Research Rate

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6 Alternate Price Number Service Provider

Manual price to override Calculated Price (e.g., special agreements)

7

Effective Date - only for alternate prices - normals will be from the annual chargemaster

Month/Day/Year Service Provider

Service added after original pricing completed

Account and Lab Set-Up Entry

Field Required Response Entered By Field Definition

1 Purchase Order # Y Number AHC User Enter the purchase order number for lab/medical services to be purchased from partner service provider (Fairview)

2 Effective Date Y Month/Day/Year AHC User Enter the purchase order effective date for lab/medical services to be purchased from partner service provider (Fairview).

3 Amount Y Number AHC User Enter the purchase order amount for lab/medical services to be purchased from partner service provider (Fairview).

4 End Date Y Month/Day/Year AHC User

Enter the purchase order expiration date for lab/medical services to be purchased from partner service provider (Fairview). Estimated end date should be entered if end date is not defined.

5 Location of Services Check boxes AHC User Select all service locations at which the research services needed will be provided.

6 In-House Lab Choose Result Report Method Select one option AHC User

Lines 6-19 should be completed if using FV labs to obtain results. Select one option for report method of labs processed by an in-house lab

7 In-House Lab Fax Results Number Number AHC User Enter the fax number if lab results will be

faxed

8 In-House Lab Results Name/address for fax header

Char, any text AHC User Enter the name and address to whom faxed lab results should be addressed

9 In-House Laboratory Site(s) Check boxes AHC User Check all laboratory sites where in-house

labs will be processed

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10 In-House Lab Specimens Collected By Check boxes AHC User

Check boxes for specimen collection

11 In-House Lab Special Collection Instructions Char, any text AHC User Enter any special collection instructions for

in-house lab specimen collection

12 In-House Lab Specimen Processed by Investigator Yes/No AHC User

Check whether the specimens will be centrifuged and separated by investigator/staff

13 In-House Lab Routine Protocol Yes/No AHC User

If centrifuge and separation will be performed by the lab, check whether there is a special protocol

14 In-House Lab Special Protocol Instructions Char, any text AHC User If there is a special protocol, enter

instructions here

15 In-House Lab Centrifuge Yes/No AHC User If lab will centrifuge check "yes", if not check "no"

16 In-House Lab Centrifuge Temperature Char, any text AHC User If lab will centrifuge, enter temperature

requirement

17 In-House Lab Specimen Storage Check boxes AHC User

Check specimen storage requirement

18 In-House Lab Processing Instructions Char, any text AHC User If lab will process - enter laboratory

processing instructions

19 In-House Lab Other Char, any text AHC User Enter any other in-house processing instructions information

20 Outside Laboratory Name Char, any text AHC User

Lines 20 - 25 apply if using an outside lab to obtain a result. If an outside or central lab will process specimens, and a lab manual is not available, enter the name of the lab

21 Outside Laboratory Address Char, any text AHC User

If an outside or central lab will process specimens, and a lab manual is not available enter the address of the lab

22 Outside Laboratory Phone Char, any text AHC User

If an outside or central lab will process specimens, and a lab manual is not available enter the phone number of the lab

23 Outside Laboratory Collection Instructions Char, any text AHC User

If an outside or central lab will process specimens, and a lab manual is not available, enter collection instructions

24 Outside Laboratory Processing Instructions Char, any text AHC User

If an outside or central lab will process specimens, and a lab manual is not available, enter processing instructions

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25 Outside Laboratory Send Out Instructions Char, any text AHC User

If an outside or central lab will process specimens, and a lab manual is not available, enter send out instructions

26 Recruitment Posting Check Box Check box AHC User

Check box if research project should NOT be posted on Fairview and AHC recruitment website

27 Recruitment Posting Categories Check boxes AHC User

If research project will be listed on Fairview and AHC recruitment website, check all categories that apply

28 Lab # Char, any text Service Provider Lab project account number

29 IDS# Char, any text Service Provider Investigational Drug Services protocol account number

30 Flowcast Study # Char, any text Service Provider Flowcast protocol number 31 Hospital Account #1 Char, any text Service Provider Hospital protocol account number

32 Hospital Account #2 Char, any text Service Provider Hospital protocol account number (if obtaining services from more than one hospital more than one is needed)

33 Hospital Account #3 Char, any text Service Provider Hospital protocol account number (if obtaining services from more than one hospital more than one is needed)

34 EPIC # Char, any text Service Provider EPIC protocol number

Subject Entry

Field Required Response Entered By Field

1 Subject # Y Char, any text AHC User Study or researcher assigned number or other unique

identification.

2 Subject Initials Y Char, any text AHC User Research subject initials. TASCS will autofill placeholders for

studies that have a Certificate of Confidentiality.. 3 Gender Y M/F AHC User Choose research subject gender

4 Medical Record # Y Number AHC User

Enter UMMC medical record number. TASCS will autofill placeholders for studies that have a Certificate of Confidentiality.

5 Birthdate Y Month/Day/Year AHC User

Enter research subject's date of birth. TASCS will autofill placeholders for studies that have a Certificate of Confidentiality.

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6 Race Drop down AHC User Choose race category for research subject 7 Ethnicity Drop down AHC User Choose ethnicity category for research subject

8 Patient Case Number Number Service Provider

Enter patient case number for subject. This will occur after the AHC User enters the date the subject signed consent on the Subject Tracking Form Entry screen.

Subject Tracking Form Entry

Field Required Response Entered By Field Definition 1 Subject # Autofill System Pulled from Subject Entry screen 2 Subject Initials Autofill System Pulled from Subject Entry screen

3

Were any new services (services not on the encounter form or lab slip) provided to the subject at this visit?

Y Yes/No AHC User

Before a visit date can be entered as completed - the following question must be answered: Were additional services used at the visit (e.g., not planned for this visit and they were not pre-printed on the Encounter Form or Research Lab Slip)? If there were additional services, indicate by choosing "Yes." If there were no additional services, indicate by choosing "No."

4

Date of Consent Y Month/Day/Year AHC User

Enter the date the subject signed the initial study consent form. This will generate an automatic e-mail to providers to assign a patient case number to each subject, if applicable.

5

Date of Visit(s) Y Month/Day/Year AHC User

Enter the date the subject completed the study visit. In situations where services for a protocol visit are provided on more than one day (for instance, an MRI for the protocol is completed in advance of the clinic visit), choose and enter the date the protocol visit was completed.

6 Date Withdrawn Y Month/Day/Year AHC User

Enter the date the subject's participation in the study ends (no further data should be collected after this date)

7 Withdrawal Reason Y Drop down AHC User

Choose the most appropriate reason from the "withdrawal reason" drop down

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8

Notes Char, any text AHC User

Use this field to store/communicate information about recording subject visit dates – e.g.”Subject 101 completed study MRI on 8/13/08 but completed study visit on 8/15/08”

Service Discrepancy Entry

Field Required Response Entered By Field Definition

1 Subject Medical Record Autofill System Data pulled from the Subject Tracking

Form for each "yes" answer

2 Visit Date Autofill System Data pulled from the Subject Tracking

Form for each "yes" answer

3 Visit Description Autofill System Data pulled from the Subject Tracking

Form for each "yes" answer

4 Service Description Y Char, any text AHC User Enter the added test/service - free text up to 35 characters

5 Service Location Y Drop down AHC User Choose the location at which service was provided

6 Added Service Payer Y Drop down AHC User Choose the payer for the additional service

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APPENDIX C

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APPENDIX D – Process Flow

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APPENDIX E – AHC Policy Clinical Research Budgeting and Billing Policy Effective: September 1, 2008 Last Updated: Responsible University Officer: AHC Assistant Vice President for Research Policy Owner: AHC Assistant Vice President for Research

Policy Contact: Mark S. Paller, MD, MS Assistant Vice President for Research, AHC Tel: 612.625.3655 Fax: 612.626.2111 palle001@umn.edu

Policy Statement

This policy clarifies compliance requirements for the budgeting and billing of clinical services, items, or tests provided to subjects who participate in clinical research, regardless of source of funding. Faculty and staff have a responsibility to ensure that budgeting and billing for costs incurred in the conduct of clinical research occurs only as appropriate and in compliance with relevant laws and regulations. Any billing to Medicare or Medicaid, to another third party insurer, or to the research subject for professional or clinical services, drugs, devices or tests provided in the context of a clinical research project must be allowable by applicable federal and state laws and regulations governing medical billing practices, by other third-party payer requirements; and must be consistent with the study budget and the clinical research consent form signed by the research subject.

As of the effective date of this Policy, each clinical research project will be conducted pursuant to a documented budgeting and billing plan that: 1) delineates the services, drugs, devices, tests, and procedures to be rendered in the context of the clinical research; and 2) states who is responsible for paying for each service, drug, device, test, or procedure.

Reason for Policy

The protocol for a clinical research project may include standard, conventional treatment for a patient’s medical condition. Often, the costs of standard care provided to a patient enrolled in clinical research may be billed to third party insurers. However, when the sponsor of the research provides funding for

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services/procedures customarily designated as standard care, these costs cannot be billed to Medicare, Medicaid, other third party insurers or the research subject.

There may also be services, items or tests that are purely experimental – not known to be effective or are required for investigational purposes only. As a general rule, costs for items and services that are experimental may not be billed to Medicare, Medicaid, other third party insurers, or the research subject. Costs for services, drugs, devices and tests that are experimental are the responsibility of the sponsor or other entity funding the research (i.e., industry, government agency, non-profit, hospital providers, or departmental funds). Under certain circumstances, as provided in law and regulation, costs for experimental services or items required as part of clinical research may be billed to a third party or to the subject so long as these elements of cost are not reimbursed by the sponsor. It is essential that the Principal Investigator (PI) determine early in the process which cost elements of a trial are standard care and which are research-specific. For each clinical research project, the PI must document the financial responsibility for paying for each service, drug, device, test or procedure.

Procedures

It is the responsibility of the PI to understand and comply with procedures to meet obligations for billing Medicare, Medicaid and third party insurers for services, drugs, devices, tests and procedures rendered in the clinical research context.

1. Before initiating an IRB application, the PI (or designee) will enter clinical research information, for each protocol, into the AHC clinical research database. The database will generate a documented billing plan based on the data entered by the PI or designee. The PI or designee will print a copy of the billing plan and attach it to the IRB application. The PI or designee will also include the billing plan with documents submitted to Sponsored Projects Administration.

2. The PI or designee will complete/update the AHC clinical research database for each person who signs a clinical research consent form, for each clinical research encounter/visit, and for each person who signs a clinical research consent when that person is withdrawn from the clinical research. This information must be entered into the AHC database within seventy-two (72) hours of the event.

It is the responsibility of the PI or designee to maintain records related to the research project and to make such records available for monitoring purposes.

Additional Contacts

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Subject Contact Phone Fax/Email Primary Contacts Trung Ngo

TASCS Web Application Support Specialist

612.626.5203 612.626.4983 ngox0035@umn.edu

Policy Mark S. Paller, MD, MS Asst Vice President for Research, AHC

612.625.3655 612.626.2111 palle001@umn.edu

Definitions

Clinical Research For the purpose of this policy, “clinical research” is defined as a systematic investigation, including research development, testing and evaluation involving human subjects, their data, records or tissue and is designed to develop or contribute to generalizable knowledge. The policy does not apply to clinical research meeting the Institutional Review Board (IRB) criteria for exemption (per 45 CFR 46.101).

Responsibilities

Principal Investigator Enter clinical research information for each protocol into the AHC clinical research database. Print a copy of the billing plan, sign it, and submit it with the initial IRB application and the final SPA Proposal Routing Form (PRF). Update the AHC clinical research database within 72 hours of the following events: each subject/participant who signs an initial consent form, each subject/participant visit that occurs, each subject/participant who ends participation in the clinical research.

Clinical Research Coordinator If delegated to the Clinical Research Coordinator by the PI: enter clinical research information for each protocol into the AHC clinical research database. Print a copy of the billing plan, obtain PI signature, and submit it with the initial IRB application and the final SPA (PRF). Update the AHC clinical research database within 72 hours of the following events: each subject/participant who signs an initial consent, each subject/participant visit that occurs, each subject participant who ends participation in the clinical research.

Unit Administrator Review the PRF for signed billing plan. Assist with purchase order preparation based on billing plan. Monitor start of activity on the account. Charge costs appropriately.

Department Head Review and approve PRF. Provide general oversight.

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Sponsored Projects Administration (SPA) Serves as a checkpoint to help assure congruent language and practice in budgeting and billing. Reviews the contract language, proposed budget and billing plan to look for uniformity. Notifies PI and requests revisions if discrepancies are identified. Contract or agreements may not be executed until discrepancies are resolved.

Institutional Review Board (IRB) Serves as a checkpoint to help assure congruent language and practice in the research consent process. Reviews language in the consent form regarding cost to the participant and matches information to the billing plan. Notifies PI when discrepancies are identified. Final IRB approval may not be granted until discrepancies are resolved.

Related Information

University of Minnesota Physicians and Fairview Health Services, the affiliated billing entities, acknowledge and agree with this policy. Each has a companion policy in support of this document.

Centers for Medicare and Medicaid Services’ National Coverage Decision, 2000.

University of Minnesota Physicians: Fairview Health Services: Association of Academic Health Centers guidance, “Investing in Clinical Research Compliance”, May, 2007.

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APPENDIX F – UMP Policy

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APPENDIX G – Fairview Policy System Policy

Code: S:LD-2030 Entity: Fairview Health Services

Manual: Corporate Compliance

Category: Leadership Subject: Research Billing Policy

Purpose: To provide clinical research billing that is accurate and in compliance with applicable regulations. The policy establishes uniform procedures for research billing to promote compliant billing practices for both the institution and the principal investigator.

Scope: This policy applies to all medical staff appointees, students, and physicians privileged to practice at Fairview, and employees of Fairview who participate in conducting research.

Definitions: Clinical Research: For the purpose of this policy, “clinical research” is defined as a systematic investigation, including research development, testing and evaluation involving human subjects, their data, records or tissue and is designed to develop or contribute to generalizable knowledge. The policy does not apply to clinical research meeting the Institutional Review Board (IRB) criteria for exemption (per 45 CFR 46.101). Institutional or Research Study Account: Specific billing account created to hold charges for a designated payer other than insurance. Fairview establishes a separate institutional or research study account for each identified clinical trial. Laboratory Request Slip: Document created by Fairview Laboratory detailing tests and procedures specific to a designated study. Also includes study title, study contact information and account numbers. Principal Investigator: The individual who conducts research, i.e., under whose immediate direction the research activities are conducted. Research Encounter form: Document created when establishing a research institutional account. The Encounter form contains study specific information such as study title, contact information, account numbers and list of requested research services. Time and Study Collection System (TASCS): University of Minnesota web-based program containing business information for clinical research. Program is user identification and password protected.

Policy: Clinical research often generates costs that are reimbursed differently. The principal investigator is responsible for determining which costs are to be charged to insurers or research participants and which will be charged to the research study. These decisions need to be consistently reflected in the clinical trial agreement and the consent form for any given research study.

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Fairview will provide access to billing experts if investigators wish consultative services when developing their budgets. Fairview, to the best of its ability, will not bill patients or their insurance when the research sponsor has agreed to pay for designated services or research related injuries. It is not acceptable to require billing of third party insurance companies in lieu of recovery of such costs from the sponsor. Fairview is responsible for correctly identifying research related charges within its systems and directing them to the appropriate payers.

Procedure: A. General Procedures

1. Fairview Research Administration will monitor daily reports from TASCS to acquire needed information.

2. Research Administration will add a research flag to individual patient records when they are identified as research participants in TASCS (e.g., consent to participate). These flags will subsequently appear on each registered patient visit.

3. Research Administration will remove the research flag from the patient information and billing account when the subject’s participation in the study has ended.

B. PASS Procedures – Institutional Accounts

1. Registration procedures at, or before, point of service are: a. Outpatient and billing to researcher: use “STU” as primary

payer code b. Outpatient and billing to payer: use “STU” as secondary

payer code c. Inpatient and billing to researcher: use “STU” as primary

payer code d. Inpatient and billing to payer: use “STU” as secondary payer

code 2. Researchers will use the study-specific research encounter form

or laboratory request slip when accessing services for research purposes. (Applies to hospital services, and hospital-based clinic services only).

3. Staff at point of service will use information from the study-specific encounter form or laboratory request slip to enter charges into billing systems. These charges are directed to institutional accounts that are invoiced to the researchers.

4. Research Administration will prepare and distribute monthly invoices for each established research institutional account.

5. Research Administration will manage the dispute resolution process (instruction available to customers in the Research User’s Manual at www.fairview.org/research)

C. PASS Procedures – Patient Accounts

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1. An edit in PASS will identify patient accounts with research flags and send accounts to Research Administration for daily review.

2. Research Administration will use TASCS data (the research billing plan/grid and patient tracking log) to verify that charges are correctly directed toward insurance.

3. Research Administration will alert HIMS regarding need for research codes or modifiers on claims.

4. If the charges are correct, Research Administration will notify Fairview’s Central Business Office (CBO), via the edit process, to release the claim. If the charges are not correct, Research Administration will make the necessary corrections.

5. The CBO will send claims to patients and third party payers. 6. The CBO will work with Research Administration to address

disputed or denied claims. D. EPIC Procedures – All Research Related Encounters

1. Registration procedure: a. Outpatient and billing to researcher: Choose account type

“Research” and locate the specific study account. b. Outpatient and billing to payer: Choose appropriate

“Pt./Family” account. 2. Research personnel, or staff conducting the visit, will ensure that

the research visit is tied to the correct account. Charges on Pt./Family accounts are routed to care system work queue. Charges on Research accounts are routed to research review work queue.

3. Research Administration will use TASCS data (the research billing plan/grid and patient tracking log) to verify whether the charges belong on the study account or the patient/family account and correct the accounts accordingly.

4. For Research Study Account Charges: a. Research Administration will prepare and distribute

monthly invoices for each research study account. b. Research Administration will manage the dispute

resolution process (instruction available to customers in the Research User’s Manual at www.fairview.org/research)

5. For Patient/Family Account Charges: a. Coders will review the claim and apply the appropriate

diagnosis codes and modifiers. b. The CBO will send claims to patients and third party

payers. c. The CBO will work with Research Administration to

address disputed or denied claims.

E. Documentation Requirements in Medical Record If the research charges are directed toward the patient or family

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accounts in either system, the following documentation must appear in the patient’s medical record:

1. Name of the clinical trial 2. Name of sponsor and sponsor protocol number 3. Device trials - must include FDA assigned Investigational Device

Exemption (IDE) 4. Humanitarian Use Devices – must include FDA assigned

Humanitarian Device Exemption (HDE) number External Ref: Center for Medicare/Medicaid Services’ Clinical Research Policy

Modernization Act, 42CFR§405.201, Medicare Benefit Policy Manual, Chapter 14, Common Rule 45CFR§46.

Internal Ref: University of Minnesota Academic Health Center’s Research Budgeting/Billing Policy, Fairview’s Research Documentation in Medical Records Policy (S:IM-2020)

Source: Approved by:

Date Effective: September 1, 2008 Date Revised:

Date Reviewed:

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APPENDIX H – Service Locations UMMC Clinics

• 1A Neuro, Neuro Surg, PMR, EEG/EMG • 2A Transplant Center • 3A Primary Care • 4A Pediatrics • 5A Allergy, Asthma, Derm, PFT Lab • 5A Sleep Disorder • 6A Medicine • 8A ENT • 9A Eye • 3B Cardiovascular Center • 5B BMT • 6B Delaware St • 1C Women’s Health Center • 1E Surgery, Colon-Rectal, GE, Weight Mgmt • 1E Peds Urology • Derm Surg and Laser • Masonic Breast Center • Masonic Day Hospital • Mayo B435 Prostate Cancer and Urology • Riverside Ortho • Riverside University Specialisits • Riverside Urology • Riverside West Psychiatry

UMP Clinics

• Masonic Cancer Center • Family Medicine • Center for Sexual Health • Smiley’s Clinic • Phalen Village • Broadway Family Medicine • Bethesda Clinic • Riverside Endoscopy Center • Imaging Center • Reproductive Medicine Center

Fairview Clinics

• Maple Grove Medical Center • Columbia Park Medical Group • Fairview Cedar Ridge • Fairview Oxboro

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• Fairview Ridges • Fairview Eagan • Fairview EdenCenter • Fairview Crosstown • Fairview Elk River • Fairview Lino Lakes • Fairview Bass Lake • Fairview Children’s • Fairview Hiawatha • Fairview Northeast • Fairview Uptown

Fairview Hospitals

• University of MN Medical Center, Fairview • Fairview Southdale Hospital • Fairview Ridges Hospital • Fairview Lakes Medical Center • Fairview Northland Medical Center • Fairview Red Wing Medical

UMP Imaging Center – on the UMMC Campus Other – not one of the locations described above

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APPENDIX I – Fairview / UMP Research Contacts

FAIRVIEW HEALTH SERVICES Research Administration Phone Email Adrienne Baranauskas, Director (612) 672-4954 abarana1@fairview.org Linda Johnson, Admin. Asst. (612) 672-7690 ljohns39@fairview.org Mike Rugani, Compliance (612) 672-7680 Mrugani1@fairview.org Angie Morris, Operations Supervisor (612) 672-7667 amorris1@fairview.org Julie Helgerson, Pricing/Billing. (612) 672-7678 Jhelger1@fairview.org Jerald (JJ) Green, Pricing/Billing (612) 672-7675 Jgreen2@fairview.org Crystal Robinson, Pricing/Billing (612) 672-7779 Crobins6@fairview.org Debbi Stockburger, Subcontracting. (612) 672-7797 Dstockb1@fairview.org Tiffany Walker, Regulatory (612) 672-7647 Twalker3@fairview.org Jodi Swedin, Research Billing Analyst (612) 672-6737 Jswedin1@fairview.org Investigational Drug Service Phone Email Main Office (612) 273-6212 dluke1@fairview.org Research Institutional Official Phone Email George Chresand Sr.V.P. and General Counsel

(612) 672-6812 Gchresa1@fairview.org

Corporate Compliance Phone Email Doug Vickers (612) 672-2217 Avicker1@fairview.org

UNIVERSITY OF MN PHYSICIANS

UMPhysicians Compliance Phone Email Tom McSteen, CCO (612) 884-0797 tmcsteen@umn.edu

UMPhysicians Billing Office Phone Email Laurie Burlingame, Pricing/Billing (763) 782-6497 lburlingame@umphysicians.umn.edu Megan Anderson, Pricing/Billing (763) 782-6582 manderson@umphysicians.umn.edu Anna Fitschen-Emberger, Supervisor (763) 782-6477 afitschen@umphysicians.umn.edu

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ANCILLARY DEPARTMENT CONTACTS Phone Email Department Julie Larson 612-273-5535 jlarso14@fairview.org UMMC/Cardiac Catheter Lab Susan Steinert 612-273-5205 Ssteine1@fairview.org UMMC/Cardiac Catheter Lab Patricia Bruggeman 612-273-6304 Pbrugge1@fairview.org UMMC/Radiology Services Sean Moen 612-273-6603 Smoen1@fairview.org UMMC/Radiology Services Maggie Wolverton 612-273-0984 Mwolver1@fairview.org UMMC/EKG & Echo Research Lab 612-273-5552 Dept-ummcu-aclabs-

research_pf@fairview.org UMMC/Laboratories

Kelly Sanocki 612-273-4995 Ksanock1@fairview.org UMMC/Endoscopy Anne Hanzel 612-273-2617 Ahanzel1@fairview.org UMMC/Perioperative

Services Mary Kay Jennrich 612-273-4088 Mjennri1@fairview.org UMMC/Perioperative

Services Kelly Ratajczak 612-273-4371 Lratakz1@fairview.org UMMC/Perioperative

Services Becki Pope 612-626-3623 bpope@umphysicians.umn.edu UMMC/EEG & EMG Cheri Hammer 952-924-5241 Chammer1@fairview.org FSH/Radiology Services Meral Atay 952-924-1449 Matay1@fairview.org FSH/Cardiovascular Services Bonnie Herda 952-924-5186 Bherda1@fairview.org FSH/Perioperative Services